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Completed

NCT Number: NCT04839133

Robotic-assisted Exercise Training in Heart Failure

Background:

Regular physical activity is an evidence-based adjuvant therapy of chronic heart failure or chronic lung diseases. Structured exercise training is safe, increases exercise capacity and quality of life, relieves symptoms and reduces hospitalization rates. Even a trend towards reduction of mortality has been identified. However, dyspnea and fatigue, typical symptoms of heart or lung failure, force patients to physical inactivity which fatally aggravates deconditioning and exercise intolerance, leading to an increased risk of hospitalization and a loss of independence and quality of life. To break through this vicious circle physical activity must be restored, since exercise intolerance can be successfully improved by physical training.

Purpose:

This study will address the challenging task of remobilizing patients with advanced chronic lung or heart failure in a functional New York Heart Association class III-IV by using an externally physically-supported exosuit movement therapy. This soft, wearable robot (fig. 1) assists mobilization according to individual needs by activating neuromuscular feedback systems, promoting physical activity and preventing early physical exhaustion. The investigators hypotheses that an exosuit-supported training increases exercise capacity and quality of life in a greater degree than non-supported training.

Methods:

The study will consist of two parts investigating i) the feasibility, tolerance and safety (n= 30) and ii) the efficacy of an exosuit device-supported training (n=30). In i) patients will perform a walking test and a set of everyday life skills or participate in a standardized rehabilitation sports program. In ii) patients will be randomized in a 2:1 ratio for an exosuit-supported or non-supported exercise training protocol, training 3 units per week for 8 weeks. Assessment of outcome will be performed by various functional, mobility and endurance tests, questionnaires and clinical parameters. Furthermore, the transfer of regained motor and balance skills to everyday life will be analyzed.

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Key information

Conditions

Heart Failure, Systolic Cardiovascular Diseases Heart Diseases Heart Failure Lung Diseases Pulmonary Disease Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

German Heart Center, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • >17 years old
  • written informed consent
  • chronic end-stage systolic heart failure without ventricular assist device, LVEF ≤ 45% OR chronic advanced pulmonary diseases
  • clinically stable for at least 6 weeks
  • ability to mobilize into standing and walking of at least 10 meters with or without rollator
  • ability to get up from a chair without rotating the upper body >45° sagittally

Exclusion criteria

  • addictions or other illnesses that impact the ability to understand the nature, scope and consequences of the trial
  • lack of knowledge of German to fully understand study information
  • pregnancy, pre-menopausal women
  • contraindications of cardiopulmonary exercising
  • BMI > 35 kg/m², waist size > 135 cm.
  • Height <150 cm, >195 cm
  • Weight<45 kg, >110 kg
  • Functional Reach Test <15,24 cm
  • Flexion contracture in the knee/hip joint >10°
  • Chronic colonization or active infection with multi-resistant pathogens

Treatment and study plan

MyoSuitFeasibility

Device

Participants will absolve feasibility tests with and without wearing a MyoSuit.

Primary outcomes

  1. Incidence of Treatment-Emergent Falls - Safety of the MyoSuit

    Time frame: 1 hour

    Patients with advanced heart or pulmonary failure will perform 6-minute walking tests and activities of daily life both with and without wearing a MyoSuit. Outcome is measured by documenting number of falls.

  2. Incidence of Treatment-Emergent Adverse Events - Safety of the MyoSuit

    Time frame: 1 hour

    Patients with advanced heart or pulmonary failure will perform 6-minute walking tests and activities of daily life both with and without wearing a MyoSuit. Outcome is measured by documenting adverse events.

  3. Exercise can be performed when wearing a MyoSuit - Feasibility and Tolerability of walking test, activities of daily life, rehabilitation exercise group.

    Time frame: 1 hour

    Patients with advanced heart or pulmonary failure will perform a 6 minute walking test, activities of daily life and a cardiac rehabilitation exercise unit. Outcome is measured dichotomously (yes/no) according to its feasibility.

  4. Necessity of assistance in exercising when wearing a MyoSuit - Feasibility and Tolerability

    Time frame: 1 hour

    Patients with advanced heart or pulmonary failure will perform a 6 minute walking test, activities of daily lif and a cardiac rehabilitation exercise unit. Outcome is measured according to a scale of assistance needed (1=no assistance, 2=little assistance, 3=much assistance, 4=not possible). 1 is minimum, 4 is maximum. The higher the score, the worse the outcome.

  5. MyoSuit assistance leads to changes in walking distance in patients with advanced heart or pulmonary failure assessed by 6-minute walking test.

    Time frame: 30 minutes

    Change of 6minute walk distance in meters will be assessed with and without MyoSuit in every participant.

Sponsors and collaborators

Lead sponsor

German Heart Institute

Other

Collaborators

  • ETH Zurich

Registry information

Official study title

Feasibility of Robotic Assisted Exercise Training in Patients With Advanced Heart Failure or Advanced Pulmonary Diseases

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 9, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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